Meet Sarah Cramer, Senior Director of Pathology Solutions at StageBio. Discover how specialized neuropathology expertise, advanced molecular techniques, and early collaboration help biotech clients de-risk programs and accelerate therapeutic development.

Can you introduce yourself, share your role at StageBio, and what initially drew you to join the team?

As Senior Director of Pathology Solutions at StageBio, I lead our talented team of pathologists who provide specialized expertise across a diverse range of service lines, including neuropathology, medical device pathology, molecular pathology, ocular pathology, immune pathology, and systemic toxicologic pathology. I am truly honored to work alongside such skilled pathologists, scientists, and histotechnicians who are passionate about advancing therapeutic development.

My neuropathology career began at Dr. Mark Butt's Tox Path Specialists LLC, a CRO that provided focused, specialized neuropathology services. The merger of Tox Path Specialists with StageBio was an exciting opportunity to bring our specialized expertise to a broader platform, offering even greater impacts for our clients.

As an anatomic pathologist with specialized training in neuropathology, I love working on direct delivery studies and have experience interpreting effects of many kinds of test articles including antisense oligonucleotides (ASOs), adeno-associated viruses (AAVs), and lipid nanoparticles (LNPs). 

What does a typical day look like for you at StageBio - from the moment you walk in to signing off on deliverables?

No two days are alike, which is one of the most enjoyable things about this role. Talking with clients to discuss study design and evaluation strategies and ensure that we're aligned with their objectives from the very beginning is highly gratifying. Connecting with our pathologists and laboratory teams helps StageBio to maintain scientific integrity, operational efficiency, and client satisfaction across our projects.

One of my favorite tasks is evaluating slides and writing reports; bringing my years of training to bear on a specific study is fascinating. I am so lucky to regularly learn new things!

Whether it's emerging technologies, novel therapeutic modalities, or innovative approaches to solving complex pathology challenges, there's always something new and exciting to discover in this field.

What are your core responsibilities at StageBio, and how do you collaborate with clients throughout their programs?

My primary responsibility is leading our pathology team while connecting seamlessly with operations, quality assurance, and commercial teams to ensure we're providing clients with efficient, high-quality science. As a pathologist, I evaluate direct delivery neuropathology studies, relying on my expertise to perform the complex evaluations our clients need.

Beyond day-to-day operations, I am also actively exploring potential ways to build new service offerings for StageBio based on evolving client needs. This means staying closely connected with our clients throughout their programs, understanding not just what they need today, but anticipating what challenges they'll face tomorrow and how we can be positioned to help them succeed. It's an incredibly rewarding collaborative process.

What are the most common challenges clients bring to you, and how does StageBio's approach help solve them?

One of the most common challenges involves meeting study objectives. Clients often need guidance on how best to tailor histopathology approaches to align with their specific study goals, and our specialized teams bring deep experience to those conversations.

Timelines are another critical factor. In today's competitive landscape, speed matters! By offering competitive timelines, we help clients get their products to market faster without compromising on quality or scientific rigor.

We also frequently work with clients on sophisticated molecular techniques, including in situ hybridization (ISH), immunohistochemistry (IHC), method development, and image analysis. These advanced molecular approaches can be make-or-break for certain programs, and StageBio’s fantastic laboratory group with extensive molecular expertise makes a real difference.

Our team always goes above and beyond for our clients! This is not just something we say; it's embedded in how we approach every single project.

How does your team leverage advanced tools and technologies to enhance evaluations, and what sets StageBio's capabilities apart?

Our breadth and depth of specialized expertise truly sets StageBio apart. We offer systemic toxicologic pathology, medical device pathology, neuropathology, molecular pathology, immune pathology, and ocular pathology with dedicated, collaborative specialists in each area.

Our expert laboratory team can provide tailored histology services to meet virtually any client objective. This is particularly powerful because our histology lab can seamlessly handle everything from exploratory molecular studies to systemic toxicology studies and everything in between, including specialized plastics histology. This versatility means that clients don't need to coordinate between multiple vendors or worry about consistency across different aspects of their program. It's a real advantage!

What's one thing drug developers often overlook in their programs that you wish they better understood?

IBA-1 immunohistochemistry!

IBA-1 IHC highlights glial reactions that may not be visible on standard H&E staining, and it provides a fantastic, highly sensitive indicator of whether or not a test article might be neurotoxic. Too often, clients don't include this evaluation upfront, but it can be critical for understanding the safety profile of therapeutics targeting the central nervous system. Incorporating IBA-1 IHC early can save significant time and resources later.

How does involving StageBio early in preclinical development improve outcomes and help de-risk client programs?

Early involvement makes all the difference. Our specialist pathologists and histologists work closely with clients to ensure that study design and histopathology approaches are optimized to meet study objectives from the very beginning. We bring years of experience to bear on these conversations, allowing us to offer informed guidance on study design that can help identify and mitigate potential risks before they become costly problems.

When you involve specialized expertise at the beginning rather than trying to retrofit solutions later, you not only save time and money, you generate better data that more effectively supports regulatory decisions and clinical progression.

What emerging technologies or methodologies in your field are transforming how therapeutic assets are evaluated, and how is StageBio adapting?

We're seeing a transformation in the breadth of nonclinical and preclinical histopathology support required across diverse therapeutic modalities. At StageBio, we're positioned to support this evolution by offering specialized expertise spanning a wide range of subspecialties, all supported by advanced exploratory techniques including IHC, ISH, and sophisticated image analysis. Our collaborative approach to developing new capabilities ensures we're always evolving to meet the real-world needs of therapeutic developers.

We are constantly exploring new possibilities for how StageBio might support our clients: If there's something you need that we don't currently offer, we want to hear about it! 

For biotech teams evaluating CRO partners, what three questions should they ask to ensure their partner adds true scientific value?

First: Can you connect directly with highly skilled scientists to discuss important questions about your programs? Direct access to expertise, not just project managers, is crucial for getting the scientific insights you need, when you need them.

Second: Does your service provider offer comprehensive, beginning-to-end histopathology support, including diverse specialist expertise, study design consultation, and advanced histology techniques? Fragmented capabilities mean fragmented solutions, and these rarely serve the client well.

Finally, and perhaps most importantly: Do you trust your CRO to treat your study as if it were their own? Our level of commitment and ownership makes all the difference in the quality of science and service you'll receive. At StageBio, we approach every study with this mindset.  Your success is our success.

To learn more about StageBio, visit us here or contact our team.